- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839851
Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids
Evaluation of Hair Cortisol in Patients With Asthma or Allergic Rhinitis Treated With Topical (Inhaled or Intranasal) Corticosteroids
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inhaled corticosteroids have proven effective in the treatment of asthma, suppressing airway inflammation and reducing bronchial hyper-responsiveness. Beneficial clinical outcomes include fewer asthmatic symptoms, increased lung function, improved asthma-specific quality of life, and fewer asthmatic exacerbations, including severe attacks resulting in hospitalization or death. ICS are commonly used when asthmatic episodes are too frequent or too severe to be controlled solely by short acting beta agonists. ICS have few adverse effects at low to medium doses, which are mainly local effects such as hoarseness and oral thrush. On the other hand, high doses of ICS are associated with systemic effects such as increased risk of skin bruising, cataracts, elevated intraocular pressure and accelerated loss of bone mass. While there is less evidence pointing towards systemic effects of low to medium doses of ICS, several studies have suggested that such an effect exists. One study demonstrated changes in the hypothalamic-pituitary-adrenal (HPA) axis with ICS administration at doses as low as 88 μg of fluticasone per day. Moreover, a study in children showed ICS did not influence basal cortisol levels but significantly reduced peak cortisol and adrenocorticotropic hormone levels.
Hence, the extent of the systemic effect of ICS at high doses and especially at low to medium doses is not fully understood. This is partly due to the nature of most of the systemic side-effects which necessitate long term follow-up of a large population of patients, but also because of technical difficulties in assessing systemic cortisol levels over a prolonged period of time.
A similar clinical conundrum exists with intranasal glucocorticoids (INGC), regarding their systemic effect. INGCs are considered the first-line of medical therapy for allergic rhinitis and are more effective than systemic antihistamines. The most common adverse effects stem from local irritation of the nasal mucosa, while systemic effects are much rarer. The effect of INGC on the HPA axis and growth has been evaluated extensively in children. Most studies, especially those with the second generation agents and recommended doses, showed no or limited HPA suppression. Despite these reassuring data, the adverse effects of INGC can be additive with those of other glucocorticoid preparations for comorbid conditions, and thus caution should be exercised. A handful of studies have demonstrated detrimental effects of INGC therapy on bone mineral density and intraocular pressure. These studies have small sample sizes and have not clearly proven whether these effects result in clinically relevant long term outcomes, such as fractures. As a result, these studies are not reflected in current practice guidelines.
Cortisol levels are routinely determined from blood, salivary or urinary samples However, these methods do not provide information on long term cortisol secretion, accounting for the variability of HPA axis activity. There is a growing pool of evidence that shows that Hair Cortisol Concentration (HCC) examination provides a reliable retrospective estimation of integrated cortisol secretion over a period of several months. Hair grows at a rate of about 1 cm/month, thus 3 cm of hair would give an indication of the cortisol levels over the previous 3 months. HCC correlates with 24h urinary cortisol levels, but not with salivary or serum cortisol, supporting use of HCC as an indicator of cortisol levels over time rather than a point measurement. HCC has been evaluated in several clinical settings in which activity of the HPA axis and cortisol levels over a period of time are of interest. Studies have demonstrated increased levels of hair cortisol in patients with stress as well as in conditions associated with stress such as pregnancy, unemployment, PTSD, alcohol withdrawal, chronic pain and myocardial infarction. Elevated levels of hair cortisol were also shown in Cushing's syndrome, with reduced levels after correction of the disorder.
No study to date has examined the correlation between the use of inhaled or intranasal corticosteroids and levels of cortisol in hair. If such a correlation exists, it would indicate systemic absorption of these topical steroids which in turn would suggest a potential for systemic side effects. In addition, and pending further studies, HCC may serve as a validated test to determine which patients are more prone to systemic side effects, as well as help in assessing compliance.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eilon Krashin, MD
- Phone Number: 972-50-4233063
- Email: eilon.krashin@clalit.org.il
Study Contact Backup
- Name: Leader Avi, MD
- Email: avi.leader@clalit.org.il
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Principal Investigator:
- Krashin Eilon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of 18 years or older
- Diagnosis of asthma or allergic rhinitis, or both.
- Planned initiation of treatment with ICS and/or INGC at study recruitment, according to routine clinical practice
Exclusion Criteria:
- Use of inhaled, systemic or topical corticosteroids at study initiation, or during the previous 6 months.
- Use of topical corticosteroid ointments or cream, or systemic corticosteroids during the study period.
- Disorders associated with disruption of HPA axis (Cushing syndrome, Addison syndrome).
- Insufficient hair for analysis
- Bleaching or use of artificial hair color.
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Asthma
Treatment with any inhaled corticosteroid
|
Use of any inhaled corticosteroid (daily frequency and dose will be registered)
Other Names:
|
Allergic rhinitis
Treatment with any intranasal glucocorticoid
|
Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)
Other Names:
|
Asthma and allergic rhinitis
Inhaled corticosteroid + intranasal glucocorticoid
|
Use of any inhaled corticosteroid (daily frequency and dose will be registered)
Other Names:
Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in concentration of hair cortisol under topical corticosteroid treatment
Time Frame: Hair cortisol concentration 3 months after initiation of treatment with inhaled or intranasal corticosteroids compared to concentration of hair cortisol at study initiation
|
The primary outcome will be evaluated separately in each of the three distinct study cohorts
|
Hair cortisol concentration 3 months after initiation of treatment with inhaled or intranasal corticosteroids compared to concentration of hair cortisol at study initiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eilon Krashin, MD, Meir Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Glucocorticoids
Other Study ID Numbers
- MMC-13-0047-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ASTHMA
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Treatment with any inhaled corticosteroid
-
Ajou University School of MedicineAstraZenecaRecruitingAsthma | Osteoporosis Risk | Osteoporotic Fractures | Osteoporosis, OsteopeniaKorea, Republic of
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveSpain
-
NovartisCompleted
-
Rafael StelmachFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)Childhood Asthma Research and Education NetworkCompletedLung Diseases | Asthma
-
University of Campania "Luigi Vanvitelli"University of Bologna; University of Rome Tor Vergata; Italian Group for the...RecruitingInflammatory Bowel Diseases | Pregnancy Complications | Crohn Disease | Ulcerative Colitis | Fertility Disorders | Delivery ProblemItaly
-
Fundación Pública Andaluza para la gestión de la...Spanish Clinical Research Network - SCReN; CIBER (Infectious diseases)Recruiting
-
Psychiatric Hospital of AtticaThriassio General Hospital of ElefsinaCompletedSurgical Procedure, Unspecified | General Medical ConditionGreece
-
Janssen Pharmaceutica N.V., BelgiumCompletedMultiple MyelomaFrance, Poland, Ukraine, Germany, Spain, Israel, Portugal, Slovenia, South Africa, Turkey, Greece, Estonia, Russian Federation, Hungary, Austria, Lithuania, Macedonia, The Former Yugoslav Republic of, Latvia, Croatia, Denmark, A...
-
AO Innovation Translation CenterNot yet recruitingBone Loss | Limb FractureGermany, United States, Korea, Republic of, Netherlands, Switzerland, United Kingdom